This study is a prospective, non-randomized trial for the treatment of fractures of the medial malleolus using lean, bioabsorbable, rare-earth element (REE) free, magnesium (Mg)-based biodegradable screws in the adult skeleton. A total of 20 patients with isolated, bimalleolar, or trimalleolar ankle fractures were recruited between July 2018 and October 2019. Fracture reduction was achieved through bioabsorbable Mg-based screws composed of pure Mg alloyed with zinc (Zn) and calcium (Ca) (0.45 wt% Zn and 0.45 wt% Ca; ZX00). Visual analogue scale (VAS) and the presence of complications (adverse events) during follow-up (12 weeks) were used to evaluate the clinical outcomes. The functional outcomes were analyzed through the range of motion (ROM) of the ankle joint and the American Orthopaedic Foot and Ankle Society (AOFAS) score. Fracture reduction and gas formation were assessed using several plane radiographs.
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Safety: Absence of (Serious) Adverse Events (SAE) throughout the study
Timeframe: 3 years after surgery
Primary Efficacy- Change of stability of the distal tibiofibular joint
Timeframe: after surgery, at 2 weeks and at 6 weeks
Primary Efficacy- Change of stability of the fracture of the medial malleolus
Timeframe: after surgery, at 2 weeks and at 6 weeks